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Clinical Trials/NCT02985008
NCT02985008
Unknown
Not Applicable

SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE

Jeong Hoon Yang1 site in 1 country1,000 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shock, Cardiogenic
Sponsor
Jeong Hoon Yang
Enrollment
1000
Locations
1
Primary Endpoint
In hospital death
Last Updated
9 years ago

Overview

Brief Summary

Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.

Detailed Description

1. The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee. 2. If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF. 3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
December 2019
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jeong Hoon Yang
Responsible Party
Sponsor Investigator
Principal Investigator

Jeong Hoon Yang

Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • 19 years old or older
  • ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.
  • ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.
  • Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
  • Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.

Exclusion Criteria

  • Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
  • Shock with cardiac arrest outside the hospital
  • People with allergic reactions to anticoagulants such as heparin.
  • Those who refused active treatment.

Outcomes

Primary Outcomes

In hospital death

Time Frame: for 1 year

Secondary Outcomes

  • Death in 28days(28days)
  • Death in 1 year(1 year)
  • hospitalization days(1 year)
  • Successful removal of left ventricular assist device (IABP, ECMO)(1 year)
  • Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.(1 year)
  • Lactate 24 hour clearance(1 year)
  • Number of days of intensive care unit Number of days of intensive care unit(1 year)

Study Sites (1)

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